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1 Rivaroxaban compared with enoxaparin for the prevention of venous thromboembolism in acutely ill medical patients Alexander T Cohen On behalf of the MAGELLAN Steering Committee and Investigators

2 Potential conflicts Dr AT Cohen is a medical consultant for and has received honoraria, consultancy and clinical trial funding from many pharmaceutical companies, including: Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, GSK, Johnson and Johnson, Mitsubishi Pharma, Pfizer, Sanofi-Aventis, Schering Plough and Takeda Dr Cohen is an advisor to the UK Government Health Select Committee, the All-party Working Group on Thrombosis, Department of Health, and the NHS on the prevention of venous thromboembolism Dr Cohen is also an advisor to Lifeblood: The Thrombosis Charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism Presentation includes discussion of the following off-label use of a drug or medical device: No Rivaroxaban is not currently approved for use in the United States

5 Background and study questions Background The optimal duration of thromboprophylaxis (short or extended) and the acutely ill patient population most likely to benefit from extended thromboprophylaxis is not well characterized Study question Is 10 days of anticoagulation with rivaroxaban non-inferior to enoxaparin? Is 35 days of anticoagulation with rivaroxaban superior to enoxaparin followed by placebo? Cohen et al,

18 Summary MAGELLAN met its primary efficacy endpoints Day 10: rivaroxaban was non-inferior to enoxaparin in reducing the risk of VTE Day 35: extended thromboprophylaxis was superior to enoxaparin followed by placebo in reducing the risk of VTE Overall bleeding rates were low, but significantly higher in the rivaroxaban arm across the entire study period Rates of other adverse events, including liver and cardiovascular events, were similar in both arms 18

19 Conclusion MAGELLAN confirms that there is a continued risk of VTE beyond the initial period of hospitalization or immobilization in acutely ill patients Based on the pre-specified net clinical benefit analysis, a consistently positive benefit-risk balance was not seen across the heterogeneous, acutely ill patient population studied, and further analysis is required to identify which groups of patients in MAGELLAN may derive benefit from thromboprophylaxis with rivaroxaban 19

Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

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